Opinion
Plaintiff Elizabeth Ann Conte developed a serious and irreversible neurological condition. She alleges her condition is due to her long-term consumption of a generic prescription drug, and that the warnings provided by the manufacturers of the drug failed to adequately warn of known dangers resulting from its long-term use. The trial court granted summary judgment in favor of all the manufacturers. Judgment was entered in favor of Wyeth, Inc. (Wyeth), the name-brand manufacturer of the drug, on two grounds: (1) Conte could not show that she or her physician relied upon warnings or product labeling disseminated by Wyeth; and (2) a name-brand pharmaceutical manufacturer owes no duty to individuals who take only generic versions of its product. The court granted summary judgment in favor of three generic manufacturers on grounds of federal preemption and Conte’s lack of reliance on their warnings or product labeling.
We hold that the common law duty to use due care owed by a name-brand prescription drug manufacturer when providing product warnings extends not only to consumers of its own product, but also to those whose doctors fоreseeably rely on the name-brand manufacturer’s product information when prescribing a medication, even if the prescription is filled with the generic *95 version of the prescribed drug. We further conclude that Conte has shown there is a material factual dispute as to whether her doctor relied on Wyeth’s product information, but that she is unable to show he relied on any information supplied by the generic manufacturer defendants. Accordingly, we reverse the judgment in favor of Wyeth and affirm the summary judgment in favor of each of the three generic manufacturers. In light of our disposition of this appeal, it is unnecessary for us to reach the generic defendants’ further contention that federal law preempts state tort claims based upon allegedly inadequate drug labeling.
Background
The defendants in these consolidated appeals manufacture and market metoclopramide, which Conte’s physician prescribed in its generic and name-brand form, Reglan, to treat her gastroesophageal reflux disease. Wyeth manufactures and markets Reglan. Defendants Purepаc Pharmaceutical Company (Purepac), Teva Pharmaceutical USA, Inc. (Teva), and Pliva, Inc. (Pliva), manufacture generic versions of metoclopramide.
Conte developed tardive dyskinesia, a debilitating and incurable neurological disorder. She alleges she developed her condition as a result of taking metoclopramide for almost four years between August 2000 and April 2004. It is undisputed that Conte took only the generic version of the medication, not Reglan. She claims that defendants knew or should have known of a widespread tendency among physicians to misprescribe Reglan and generic metoclopramide for periods of 12 months or longer, even though the medication is only approved for 12 weeks of use, because the drug’s labeling substantially understates the risks of serious side effects from extended use.
Her complaint, after various pretrial amendments, asserts claims for fraud, fraud by concealment and negligent misrepresentation 1 against Wyeth; negligence, strict products liability, negligence per se, and breach of express and implied warranties against the generic manufacturers; and medical negligence against her doctor, Robert Elsen, M.D. The crux of Conte’s claims against all of the drug company defendants is that she was injuriously overexposed to metoclopramide due to their dissemination of false, misleading and/or incomplete warnings about the drug’s side effects.
*96 Purepac successfully moved for summary judgment on the ground that Conte’s claims against it are preempted by the Federal Food, Drug, and Cosmetic Act (FDCA) (21 U.S.C. § 301 et seq.) and its implementing regulations. Pliva and Teva subsequently filed a joint motion for summary judgment on the same basis. While the Pliva/Teva motion was pending, Wyeth moved separately for summary judgment arguing its product information had no causal relationship to Conte’s injuries and it owed her no duty of care. Unlike the generic manufacturers, it did not assert that Conte’s claims were preempted by federal law. Pliva (but not Purepac or Teva) joined in Wyeth’s motion asserting a lack of causation, and argued Conte could not prove any alleged inadequacies in its own labeling 2 caused her injuries because neither she nor her doctor relied on it.
The court granted Wyeth’s motion on both grounds. The court found that neither Conte nor her doctor relied on drug information provided by Wyeth, and that as a name-brand manufacturer, Wyeth owes no duty of care to the users of generic versions of its name-brand drug. The court subsequently granted the Pliva/Teva summary judgment motion on the ground that Conte’s state tort claims were preempted by federal law.
Conte timely appealed the judgments in favor of each company. We granted her unopposed motion to consolidate the appeals for purposes of briefing, oral argument, and decision.
Discussion
I. Summary Judgment Standards
“ ‘To secure summary judgment, a moving defendant may prove an affirmative defense, disprove at least one essential element of the plaintiff’s cause of action [citations] or show that an element of the cause of action cannot be established [citations]. [Citation.] The defendant “must show that under no possible hypothesis within the reasonable purview of the allegations of the complaint is there a material question of fact which requires examination by trial.” [Citation.] [f] The moving defendant bears the burden of proving the absence of any triable issue of material fact, even though the burden of proof as to a particular issue may be on the plaintiff at trial. [Citation.] . . . Once the moving party has met its burden, the opposing party bears the burden of presenting evidence that there is any triable issue of fact
*97
as to any essential element of a cause of action.’ ”
(Ochoa v. Pacific Gas & Electric Co.
(1998)
“In reviewing the propriety of a summary judgment, the appellate court must resolve all doubts in favor of the party opposing the judgment. [Citation.] The reviewing court conducts a de novo examination to see whether there are any genuine issues of material fact or whether the moving party is entitled to summary judgment as a matter of law.”
(M.B. v. City of San Diego
(1991)
“We need not defer to the trial court and are not bound by the reasons for the summary judgment ruling; we review the ruling of the trial court, not its rationale.”
(Knapp v. Doherty
(2004)
II. Relevant Federal Regulation
Wyeth and the generic manufacturers market their respective metoclopramide products under the FDCA. Section 505 of the FDCA, title 21 United States Code section 355, forbids the distribution of any new drag unless an application has been approved by the federal Food and Drag Administration (FDA).
A name-brand manufacturer seeking to market a new prescription drug must submit a new drug application, supported by extensive studies of the drug’s safety and effectiveness. (21 U.S.C. § 355(a)-(i); see
Colacicco v. Apotex, Inc.
(E.D.Pa. 2006)
*98 The second type of marketing application considered by the FDA is the abbreviated new drug application. The abbreviated new drug application mechanism was established in 1984 by the Drug Price Competition and Patent Term Restoration Act of 1984 (Pub.L. No. 98-417, 98 Stat. 1585; the “Hatch-Waxman Amendments” to the FDCA) to reduce the time and cost required to obtain FDA approval for generic versions of approved drugs. (See Colacicco v. Apotex, Inc., supra, 432 F.Supp.2d at pp. 522-523.) Under the Hatch-Waxman Amendments, a generic manufacturer is not required to submit independent evidence of the drug’s safety and efficacy. Instead, the generic manufacturer need only certify that the generic product is a bioequivalent of the name-brand drug and that the labeling and warnings for the generic drug are identical to those for the approved name-brand or “listed” drug. 3 (21 U.S.C. § 355(j)(2)(A).)
III. Wyeth’s Motion: Causation, Reliance and Duty
A. Causation/Reliance
Conte’s claims against Wyeth are premised on misrepresentations in Wyeth’s labeling of Reglan and in a monograph on Reglan it provided for the Physician’s Desk Reference (PDR). 4 It is undisputed that Wyeth (or its predecessor in interest) prepared the PDR monograph on Reglan/metoclopramide, which is identical to the FDA-approved package insert. Wyeth contends the trial court correctly mled that Conte cannot establish causation because she cannot show that her prescribing physician, Dr. Elsen, relied on its allegedly inadequate warnings about Reglan when he planned her treatment. 5 The record, reviewed in accord with the standards required for summary judgment, reveals a factual dispute that refutes Wyeth’s contention.
*99
Wyeth argues it produced undisputed evidence that Dr. Elsen did not rely on its product warnings when he prescribed metoclopramide to Conte. It bases its argument on Dr. Elsen’s statement in his declaration that “[a]t no time did I rely in any way on representations made in the PDR monograph, package insert, labeling materials or other information from Wyeth regarding the medication Reglan in order to formulate my course of care and treatment for Ms. Conte.” Without more, we would agree that Dr. Elsen’s statement would prevent Conte from proving he relied on Wyeth’s alleged misrepresentations in its product information. (See
Ochoa
v.
Pacific Gas & Electric Co., supra,
But, there is more. Dr. Elsen’s deposition testimony submitted by Conte in opposition to Wyeth’s motion raises significant questions about the import of his declaration. Dr. Elsen testified in his deposition that he “probably” read Wyeth’s monograph on Reglan in the PDR during his residency training; that the PDR was one of the sources he generally refers to in his clinical practice when he considers prescribing Reglan for his patients; and that he believed the information it contained was accurate. 6 Dr. Elsen also had no recollection of having prescribed Reglan for Ms. Conte, but his lack of recollection testimony is contradicted by pharmacy records and his secretary’s testimony. Accordingly, there are disputed factual issues as to both the accuracy of Dr. Elsen’s recollection and, evеn if he did not specifically refer to the PDR when he formulated Conte’s treatment, whether information he had previously garnered from the PDR was a substantial factor in his decision to prescribe Reglan for her.
Wyeth relies on
Motus v. Pfizer Inc.
(C.D.Cal. 2001)
We also are unpersuaded by Wyeth’s contention that it was Conte’s burden to also demonstrate that a stronger warning in the PDR would have affected Dr. Elsen’s decision to prescribe the drug to her. The premise of Wyeth’s causation argument was that Dr. Elsen never read Wyeth’s disclosures, so any allegedly inadequate information they contained could not have affected his decision. Wyeth did not seek summary judgment on the ground that Elsen would have made the same treatment decision even if Wyeth had disclosed a higher risk of adverse side effects. Conte was not required to demonstrate a dispute over a factual issue not raised by Wyeth’s summary judgment motion.
B. Comparisоn of Fault-based and Strict Products Liability Theories
Conte readily admits that she took only generic metoclopramide, and not the name-brand Reglan that was made and distributed by Wyeth. She argues that Wyeth can be liable for her injuries because a name-brand manufacturer that disseminates information about its product owes a duty of care to ensure the information’s accuracy to any doctor who prescribes the drug in reasonable reliance on that information, even if the patient ends up taking the name-brand product’s generic equivalent. Wyeth argues, and the trial court agreed, that it cannot be held liable to Conte for her injuries caused by generic metoclopramide because Wyeth has no duty to users of the generic *101 version of its products, which are produced by other manufacturers. The issue is apparently one of first impression in California.
As a preliminary matter, we reject Wyeth’s syllogism premised upon products liability doctrine that (1) this is merely a products liability lawsuit disguised as an action for fraud and misrepresentation; and (2) Conte cannot prevail on a strict products liability claim because Wyeth did not manufacture or sell the product that allegedly caused her injury; so (3) Conte loses. The conclusion would be sound were Conte in fact pursuing a cause of action against Wyeth for strict products liability. But she is not. The complaint alleges that Wyeth made intentional and/or negligent misrepresentations about the safety of metoclopramide, the risks of its long-term use, and the likelihood of its serious side effects.
7
She does not allege that Wyeth is strictly liable because inadequate warnings rendered its product unreasonably dangerous. (See, e.g.,
Carlin v. Superior Court, supra,
Negligence and strict products liability are separate and distinct bases for liability that do not automatically collapse into each other because the plaintiff might allege both when a product warning contributes to her injury. “ ‘[Fjailure to warn in strict liability differs markedly from failure to warn in the negligence context. Negligence law in a failure-to-wam case requires a plaintiff to prove that a manufacturer or distributor did not warn of a particular risk for reasons which fell below the acceptable standard of care, i.e., what a reasonably prudent manufacturer would have known and warned about. Strict liability is not concerned with the standard of due care or the reasonableness of a manufacturer’s conduct. The rules of strict liability require a plaintiff to prove only that the defendant did not adequately warn of a particular risk that was known or knowable in light of the generally recognized and prevailing best scientific and medical knowledge available at the time of manufacture and distribution. Thus, in strict liability, as opposed to negligence, the reasonableness of the defendant’s failure to warn is immaterial. [j[] Stated another way, a reasonably prudent manufacturer might reasonably decide that the risk of harm was such as not to require a warning *102 as, for example, if the manufacturer’s own testing showed a result contrary to that of others in the scientific community. Such a manufacturer might escape liability under negligence principlеs. In contrast, under strict liability principles the manufacturer has no such leeway; the manufacturer is liable if it failed to give warning of dangers that were known to the scientific community at the time it manufactured or distributed the product.’ [Citation.] Similarly, a manufacturer could not escape liability under strict liability principles merely because its failure to warn of a known or reasonably scientifically knowable risk conformed to an industry-wide practice of failing to provide warnings that constituted the standard of reasonable care.” (Carlin v. Superior Court, supra, 13 Cal.4th at pp. 1112-1113.)
Accordingly, the trial court was correct in its assumption that “this is a case involving legal principles of negligent misrepresentation, and not a products liability action.” For this reason, Wyeth’s reliance on numerous strict products liability cases for the rule that a plaintiff in a products liability case must prove the defendant made or sold the allegedly defective product that causes injury sheds no light on the issue presented for our consideration. (See
Bockrath v. Aldrich Chemical Co.
(1999)
Our decision today is rooted in common sense and California common law. We are not marking out new territory by recognizing that a defendant that authors and disseminates information about a product manufactured and sold by another may be liable for negligent misrepresentation where the defendant should reasonably expect others to rely on that information and the product causes injury, even though the defendant would not be liable in strict products liability because it did not manufacture or sell the product. (See
Hanberry v. Hearst Corp.
(1969)
*103 C. Duty Analysis
We will analyze Wyeth’s duty in context and consider whether a name-brand prescription drug manufacturer in disseminating product warnings owes a duty of care to patients who take a generic version of the drug pursuant to a prescription written in reliance on the name-brand maker’s information. The parties cite no California authority directly on point, and our research has disclosed none. However, we do not write on a completely blank slate.
1. Foreseeability
For over 80 years, the common law has examined duty in light of the risk undertaken by the actor charged with negligence. “The risk reasonably to be perceived defines the duty to be obeyed, and risk imports relation; it is risk to another or to others within the range of apprehension.”
(Palsgraf v. Long Island R. R. Co.
(1928)
Section 310 of the Restatement addresses intentional misrepresentations, and states that “[a]n actor who makes a misrepresentation is subject to liability to another for physical harm which results from an act done by the other or a third person in reliance upon the truth of the representation, if the actor [j[] (a) intends his statement to induce or
should realize that it is likely to induce action by the other, or a third person,
which involves an unreasonable risk of physical harm to the other, and [][] (b) knows [f] (i) that the
*104
statement is fálse, or [f] (ii) that he has not the knowledge which he professes.” (Italics added.) Section 311 provides that, “[o]ne who negligently gives false information to another is subject to liability for physical harm caused by action taken by the other in reasonable reliance upon such information, where such harm results [j[] (a) to the other, or [][] (b)
to such third persons as the actor should expect to be put in peril by the action taken”
(Italics added.) “In this context, ‘duty’ and ‘reasonable reliance’ are closely connected. The likelihood that one’s statements about рersonal safety will be taken seriously is a primary factor in determining whether one has a duty to exercise care in making such statements. As the Restatement puts it, such a duty ‘extends to any person who, in the course of an activity which is in furtherance of his own interests, undertakes to give information to another, and knows or should realize that the safety of the person or others may depend on the accuracy of the information.’ ”
(Garcia, supra,
Garcia is instructive. There, the court considered whether a parole officer bore a duty of reasonable care to a parolee’s prior victim when he told her the parolee would “not come looking for her” after his release. The parolee did just that and subsequently kidnapped and shot his prior victim. (Garcia, supra, 50 Cal.3d at pp. 731-733.) Relying on section 311 of the Restatement, the Supreme Court analyzed the parole officer’s duty by “asking whether a reasonable parole officer, having chosen for whatever reason to provide information to a potential victim about a parolee’s dangerousness, ‘knows or should realizе that [the listener’s] safety . . . may depend on the accuracy of the information.’ ” (Garcia, supra, at pp. 735-736.) Because it is foreseeable that a member of the public might reasonably believe a parole officer has special knowledge or reliability, the court concluded that once the officer chose to communicate information about the parolee to the victim, he had a duty to use reasonable care in doing so. (Id. at p. 736.) Subsequently, in Randi W. the Supreme Court extended Garcia when it considered whether a school district’s misrepresentations about a former employee in a letter of recommendation could render the school district liable for the employee’s molestation of a student in his new employment. The court held that, “consistent with Restatement Second of Torts sections 310 and 311,” the writer of the recommendation owed a duty not to misrepresent the relevant facts if the misrepresentations would present a foreseeable and substantial risk of harm to a third party. (Randi W, supra, 14 Cal.4th at pp. 1070, 1077, 1081.)
As in
Garcia
and
Randi W.,
in this case our duty analysis must look primarily to the foreseeability of physical harm. “Although foreseeability is most oftеn a question of fact for the jury, when there is no room for a
*105
reasonable difference of opinion it may be decided as a question of law.”
(Hedlund v. Superior Court
(1983)
2. Other Factors That Bear on a Determination of Duty (“Rowland Factors”)
In addition to foreseeability, California law also identifies various policy factors courts are to consider when they determine whether a duty of care exists in a novel situation.
(Randi W., supra,
We are not persuaded that the application of these factors supports a departure in this case from the general rule that all persons have a duty to use ordinary care to prevent harming others.
13
(See
Randi W, supra,
Turning to the next Rowland factor, we cannot assess the moral culpability of Wyeth’s conduct on this record. If Wyeth intentionally, or even negligently, excluded a warning from its product information, it may be morally culpable for the resulting harm. On the other hand, it is possible that the information available to Wyeth was so scientifically unsubstantiated that it was not below the standard of care to omit any warning for the product information. While full assessment of this factor must await the outcome of trial, we think one thing is clear: that if Wyeth misrepresented the risks of taking its medication, any moral culpability it might bear for that misrepresentation is not lessened if the person who is harmed by his or her reliance on it happened to ingest the generic version as a result, rather than Wyeth’s Rеglan brand.
We are unpersuaded by Wyeth’s assertion that imposing liability would undermine the goal of preventing future harm because it would chill innovation in the pharmaceutical industry. No evidence was introduced on summary judgment to support this supposition, much less to permit an informed balancing of such a risk against the harm to patients that might be prevented by recognizing a duty of care.
*107 We are also in no position to assess whether holding that Wyeth owed a duty to Conte will subject Wyeth to “permanent and uncontrolled liability” “in perpetuity.” Although Wyeth makes the argument, it appears Wyeth no longer has primary responsibility for Reglan-related claims arising after March 31, 2002.
While there is much that could and will be said in various fora about the burdens, societal consequences, cost, and insurance implications of Wyeth’s potential liability, the limited record on summary judgment does not provide the information necessary to inform such a debate. These broader consequences of the duty we identify today cannot be considered on the limited facts in the record.
On the record that
is
before us, we find the conclusion inescapable that Wyeth knows or should know that a significant number of patients whose doctors rely on its product information for Reglan are likely to have generic metoclopramide prescribed or dispensed to them. “In the absence of ‘overriding policy considerations . . . foreseeability of risk [is] of . . . primary importance in establishing the element of duty.’ [Citations.] As a classic opinion states: ‘The risk reasonably to be perceived defines the duty to be obeyed.’ ”
(Dillon v. Legg, supra,
3. Foster v. American Home Products Corp.
In the absence of California authority directly on point, Wyeth urges us to follow law from other jurisdictions that have rejected the proposition that name-brand drug manufacturers may be liable under theories of misrepresentation for injuries resulting from the use of a generic equivalent. The seminal case principally relied upon by the trial court is
Foster, supra,
In
Foster,
the parents of an infant who died after ingesting generic promethazine sued Wyeth, the name-brand manufacturer of Phenergan.
14
The
*108
complaint alleged negligence, strict liability, breach of warranty and negligent misrepresentation.
(Foster,
supra,
The federal District Court for the District of Maryland granted summary judgment in Wyeth’s favor on the negligence, strict liability and breach of warranty counts. As to the plaintiffs’ negligent misrepresentation theory, however, the court found it was immaterial that Wyeth did not manufacture the drug the child ingested. The trial court reasoned that Wyeth could be liable for the injury, without reference to any products liability-based theory, if (1) it made false representations about the drug’s safety for treating infants; and (2) the prescribing doctor relied on those representations in prescribing gеneric promethazine. 15 (Foster, supra, 29 F.3d at pp. 167-168.) The Fourth Circuit Court of Appeals reversed. Applying Maryland law, it held the manufacturer of a name-brand prescription drug cannot be held liable under a theory of negligent misrepresentation for an injury arising from the use of a generic version of the drug. Because Foster appears to be the leading case on this issue, we examine its analysis in detail.
As the trial court did in this case, the
Foster
court first criticized the plaintiffs’ negligent misrepresentation claim as an attempted end run around the requirements of products liability law and, specifically, the requirement that the plaintiff must prove the defendant made the injurious product.
(Foster, supra,
Foster goes on to consider and reject the plaintiffs’ argument that they can pursue a negligence claim against Wyeth based on its product labeling *109 because, as a name-brand manufacturer, it knows that (1) generic manufacturers simply rely on and duplicate their labeling; and (2) prescriptions for the name-brand drug may be filled with the generic version. Although the court did not dispute these basic factual premises, it concluded that to impose a duty under these circumstances would “stretch the concept of foreseeability too far.” (Foster, supra, 29 F.3d at pp. 170-171.) The Fourth Circuit’s reasoning for this determination seems circular, and we will not employ it here.
Foster
starts its analysis of duty by stating the basic principle that, as in California, foreseeability is the principal determinant of duty where the risk created is one of personal injury.
(Foster, supra,
Foster
also supports its holding with various policy reasons that we consider unpersuasive. It reasons it would be unfair to allow misrepresentation actions against name-brand manufacturers for injuries caused by generic drugs because name-brand makers bear the expense of developing, testing, and formulating lаbeling information for new medications, while generic manufacturers merely “rid[e their] coattails” by duplicating the innovator’s successful drugs and labels.
(Foster, supra,
We find the reasoning problematic. As Conte asks, what is unfair about requiring a defendant to shoulder its share of responsibility for injuries caused, at least in part, by its negligent or intentional dissemination of inaccurate information? California law is well established that concurrent *110 tortfeasors whose separate acts contribute to an injury are each liable (5 Witkin, Summary of Cal. Law (9th ed. 1988) Torts, § 49, pp. 116-117), and we see nothing novel or unjust in recognizing application of the rule in the present circumstances. The circumstances certainly do not warrant creating an exception to the general rule of concurrent liability. 16
We are also reluctant to create an exception to the general rule of duty based on the very limited “fairness” analysis permitted on the summary judgment record before us. While we have no reason to doubt that generic manufacturers do not invest the same time and expense in research and development of their products as innovators (see
Foster, supra,
We are aware that in declining to follow
Foster we
depart from the majority of courts to have wrestled with this particular issue. (See
Colacicco v. Apotex, Inc., supra,
IV. The Generic Defendants: Pliva, Teva, and Purepac
A. Pliva
Pliva joined Wyeth’s motion on the ground that Conte could not prove any alleged inadequacy in its own labeling caused her injury, and asserted as an additional undisputed material fact that Dr. Elsen did not rely on the Pliva package insert in determining the proper treatment for Conte. 18 Although Conte opposed the joint summary judgment motions with evidence that Dr. Elsen “probably” read the Reglan PDR monograph and believed it to be accurate, her opposition was bare of any evidence (or assertion) that Dr. Elsen relied on information disseminated by Pliva. Critically, she concedes on appeal that “[n]o evidence indicates that the generic defendants disseminated any information concerning their metoclopramide products aside from price lists (distributed to pharmacists) and package inserts, *112 distributed with wholesale shipments, as required by 21 C.F.R. § 201.100. No evidence suggests that Dr. Elsen relied on either the price lists or the package inserts for generic metoclopramide, if and when he wrote or ordered Ms. Conte’s Reglan prescriptions.” (Italics added.)
Conte’s concessions preclude Pliva’s liability. “There is no requirement that a manufacturer must give a warning which could not possibly be effective in lessening the plaintiff’s risk of harm.”
(Rosburg v. Minnesota Mining & Mfg. Co.
(1986)
Conte argues that
Huynh v. Ingersoll-Rand
(1993)
B. Purepac and Teva
Our resolution of summary judgment in favor of Pliva brings us to an interesting question concerning Purepac and Teva. Of the three generic defendants, only Pliva joined with Wyeth and sought summary judgment on the lack of Dr. Elsen’s reliance on its warning. Teva and Purepac did not. But Conte impliedly conceded there is no evidence that Dr. Elsen relied on product information рrovided for generic metoclopramide by responding to the Wyeth and Pliva motions only with evidence of reliance on Wyeth’s PDR monograph. Moreover, her appellate brief states explicitly: “No evidence indicates that the generic defendants disseminated any information concerning their metoclopramide products aside from price lists (distributed to pharmacies) and package inserts, distributed with wholesale shipments, as required by 21 C.F.R. § 201.100. No evidence suggests that Dr. Elsen relied on either the price lists or the package inserts for generic metoclopramide, if and when he ordered or wrote Ms. Conte’s Reglan prescription.” This concession leads implacably to the conclusion that Conte cannot prove that any of the three generic makers is responsible for her injury. Given the state of the evidence, we think it would be inappropriate to consider the federal preemption issues presented in this appeal.
It is well established that a reviewing court must affirm a grant of summary judgment if it is correct on any legal theory, as long as the parties had an adequate opportunity to address the theory in the trial court.
20
(Carnes v. Superior Court
(2005)
*114
It would also be an inappropriate use of judicial resources for this court to review the propriety of the trial court’s ruling on preemption. To address whether federal law preempts state tort liability against these defendants would be to perform an “idle act” because Conte concedes that she cannot show her doctor relied on representations by any of the generic manufacturers. (See, e.g.,
Estate of Hoffman
(2002)
We affirm the grant of summary judgment in favor of each of the three generic defendants. 21
V. Conclusion
We hold that Wyeth’s common law duty to use due care in formulating its product warnings extends to patients whose doctors foreseeably rely on its product information when prescribing metoclopramide, whether the prescription is written for and/or filled with Reglan or its generic equivalent. The risk of harm to such a patient is foreseeable to Wyeth. To hold otherwise in this case would ignore the reality of the breadth and effect of Wyeth’s representations in modem commerce and depart from firmly established principles оf fault-based tort liability.
*115 Disposition
The judgment in favor of Wyeth is reversed. The judgments in favor of Purepac, Pliva, and Teva are affirmed. The parties are to bear their own costs on appeal.
McGuiness, P. J., and Poliak, J., concurred.
A petition for a rehearing was denied November 26, 2008, and the petitions of both appellant and respondent Wyeth, Inc., for review by the Supreme Court were denied January 21, 2009, S169116. Baxter, J., was of the opinion that the petition of respondent Wyeth, Inc., should be granted.
Notes
Schwarz Pharma, Inc., is named as an additional defendant in the negligent misrepresentation claim. The complaint alleges Schwarz purchased the rights and liabilities associated with Reglan tablets and syrup from Wyeth in December 2001 pursuant to an asset purchase agreement that made Schwarz responsible for Reglan-related claims arising from and after March 31, 2002, subject to a right to indemnification by Wyeth up to an amount not known to Conte.
Labeling includes package inserts, which are the primary form of labeling for prescription drugs.
(Sykes
v.
Glaxo-SmithKline
(E.D.Pa. 2007)
“Bioequivalence exists when there is no significant difference between the rate and extent of аbsorption of two drugs with the same active ingredients administered at the same molar dose under similar experimental conditions, or when a difference in the extent of absorption in such circumstances is not medically significant and certain other requirements are met.”
(Foster v. American Home Products Corp.
(4th Cir. 1994)
“The PDR is an annual publication compiling product information about pharmaceuticals. The information is provided by the drug manufacturers and is approved by the F[DA]. Each year the PDR and its supplements are sent free of charge to licensed physicians in the United States and abroad. A typical entry includes the trade name and chemical name of the drug, a description of the drug, indications and contraindications for its use, warnings, adverse reactions, administration and dosage, and information on managing and adjusting the dosage of the drug.”
(Morlino
v.
Med. Ctr. of Ocean Co.
(1996)
Because metoclopramide is a prescription drug, under the learned-intermediary doctrine Wyeth’s duty to warn of risks associated with its usage runs to the physician, not the patient.
*99
Carlin v. Superior Court
(1996)
The testimony in full reads: “Q: All right. Can you recall if there came a point in time in your residency training when you had occasion to consult and read the P[DR] monograph about Reglan brand metoclopramide? [f] A: I don’t recall specifically reading about it in the PDR but I read about many different medications in the PDR. It was a frequently-used drug so I probably did look at the PDR during that time regarding Reglan. [][]... [f] Q: During the course of your clinical practice here in San Francisco when you would think about prescribing Reglan for your patients did you rely on the accuracy of the information that was available to you in the [PDR] concerning Reglan? [][] A: The PDR would be one of the sources I would refer to but just one of the sources.” Asked whether, if he did consult the PDR about Reglan, he would have relied on it as being accurate, Dr. Elsen responded affirmatively.
Intentional and negligent misrepresentations are both actionable forms of fraud. (Civ. Code, § 1710.) While intentional misrepresentation requires an assertion of fact by one not believing it to be true (§ 1710, subd. 1), a statement made without a reasonable basis to believe it is true and the suppression of fact by one bound to disclose it are also actionable. (§ 1710, subds. 2-3.) For purposes of our discussion, negligent misrepresentation will subsume intentional fraud.
Nor, contrary to Wyeth’s suggestion, is there any indication in the record that Conte is proceeding under a market-share liability theory (see
Sindell
v.
Abbott Laboratories
(1980)
One California court has sought to distinguish the
Palsgraf
formulation of duty in a premises liability context.
(Hassoon
v.
Shamieh
(2001)
The general rule as formulated in California is thus informed by both common law and civil law principles since it is formed by cases and reflected in statute. (See
Rowland
v.
Christian
(1968)
All further references to the Restatement are to the Restatement Second of Torts.
Business and Professions Code sectiоn 4073 provides in part: “(a) A pharmacist filling a prescription order for a dmg product prescribed by its trade or brand name may select another drug product with the same active chemical ingredients of the same strength, quantity, and dosage form, and of the same generic drug name as determined by the United States Adopted Names (USAN) and accepted by the federal F[DA], of those drug products having the same active chemical ingredients. Q] (b) In no case shall a selection be made pursuant to this section if the prescriber personally indicates, either orally or in his or her own handwriting, ‘Do not substitute,’ or words of similar meaning. Nothing in this subdivision shall prohibit a prescriber from checking a box on a prescription marked ‘Do not substitute’; provided that the prescriber personally initials the box or checkmark. . .. Q] (c) Selection pursuant to this section is within the discretion of the pharmacist, except as provided in subdivision (b). ... In no case shall the pharmacist select a drug product pursuant to this section unless the dmg product selected costs the patient less than the prescribed drag product. . . .”
Wyeth contends
Rowland
is inapplicable because in this case “the law has already specifically determined that no duty exists.” (See
Mastro v. Petrick
(2001)
The parents also sued the generic manufacturer, but agreed to a dismissal with prejudice for reasons not stated in the record.
(Foster, supra,
On a second motion, the court granted summary judgment for Wyeth on the ground that the plaintiffs could not show their doctor actually relied on any representatiоns made by Wyeth.
(Foster, supra,
We are not persuaded by the trial court’s warning that allowing misrepresentation claims in these circumstances would, in effect, “hold the pioneer manufacturer liable as insurer” for its generic competitors. The liability in question here is based on reasonable and foreseeable reliance on the manufacturer’s misleading written information about the risks of a drug, not on information disseminated by a generic competitor or on defects in the formulation or manufacture of the competitor’s drug. For the same reason, we believe the fact that the name-brand manufacturer has no control over the
production
of the generic competitor’s products is not relevant to this narrow inquiry, and we question
Foster’s
emphasis of that fact. (See
Foster, supra,
Goldych relied in part on New York case law that where “ ‘alleged fraudulent acts are the same acts underlying the negligence and strict products liability causes of action, there is nо distinct cause of action for fraud.’ ” (Goldych v. Eli Lilly & Co., supra, 2006 U.S.Dist. Lexis at p. *20, fn. 11.) Wyeth has not pointed this court to any parallel California law.
Pliva also joined the other generic defendants in seeking summary judgment on federal preemption grounds.
To be clear, there is no evidence in this case that Dr. Elsen relied on information provided by sales representatives for either Wyeth or the generic manufacturers.
We have considered briefs solicited from the parties in compliance with Code of Civil Procedure section 437c, subdivision (m)(2), which requires a reviewing court to invite supplemental briefs before affirming a summary judgment on grounds not relied upon by the trial court. (See
Shamsian
v.
Atlantic Richfield Co.
(2003)
We deny Pliva’s request for judicial notice of an FDA proposed rule because consideration of the proposed rule is unnecessary for our resolution of the appeal.
(Mangini v. R. J. Reynolds Tobacco Co.
(1994)
